Kornimate/medical-research-clean huggingface dataset:
memantine and naltrexone treatment for opioid dependence

Conditions: Opioid Dependence

Summary: the goal of this study is to test the efficacy of memantine (a noncompetitive nmda receptor antagonist) as an adjunct to the maintenance treatment with naltrexone in detoxified heroin-dependent individuals.

the primary aim of this study is to test the efficacy of memantine, a noncompetitive nmda receptor antagonist, in reducing early attrition and improving outcome in opioid-dependent individuals maintained on naltrexone. this double-blind, 12-week trial will include heroin-dependent patients who completed detoxification. participants will be randomly assigned to one of three conditions: naltrexone and placebo, naltrexone and memantine (15 mg bid), or naltrexone and memantine (30 mg bid). naltrexone will be taken 3 times each week at the clinic, while memantine or placebo will be taken at home. in addition, twice each week patients will receive a psychosocial intervention that will include motivational interviewing and cognitive-behavioral relapse prevention. the goal of the psychosocial intervention is to improve compliance with medication and maintain abstinence. baseline assessments will be taken and compared to those completed at study visits, which will occur 3 times each week.

Eligibility criteria:
inclusion: * adult, aged 18-60. * meets dsm-iv criteria for current opiate dependence disorder of at least six months duration, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear. * able to give informed consent. exclusion: * pregnancy or breastfeeding * failure in a sexually active woman to use adequate contraceptive methods * active medical illness that might make participation hazardous, such as untreated hypertension, acute hepatitis with sgot or sgpt levels \> 2 times normal, unstable diabetes, or chronic organic mental disorder (e.g., aids dementia) * active psychiatric disorder that might interfere with participation or make participation hazardous, including dsm-iv schizophrenia, bipolar disorder with mania or psychosis, and depressive disorder with suicide risk or 1 or more suicide attempts within the past year. * history of allergic reaction to buprenorphine, naloxone, memantine, naltrexone, clonidine, or clonazepam * currently prescribed or regularly taking opiates for chronic pain or medical illness * current participation in another intensive psychotherapy or substance abuse treatment program or currently prescribed psychotropic medications * current participation in a methadone maintenance treatment program and/or regular use of illicit methadone ( \> 30 mg per week) * history of accidental drug overdose in the last 3 years or any other significant history of overdose following detoxification, defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received

Keywords: heroin opiates naltrexone memantine
effectiveness of kt vs st along with routine physical therapy among patients of chronic low back pain rct

Conditions: Low Back Pain

Summary: to determine the effectiveness of kineso taping (kt) versus sham taping along with routine physical therapy among chronic low back pain (clbp) patients.


Eligibility criteria:
inclusion criteria: pain in the area between 12 ribs and hip crease with or without leg pain. age ranges from 18 to 65 years. low back pain for 6 weeks. moderate pain intensity with pain score. exclusion criteria: known or suspected spinal lesions. spinal surgery within first 6 months. physical therapy for low back pain for past 6 months. severe complications.
tnfalfa blocking treatment of spondylarthropathies

Conditions: Spondylarthropathies; Ankylosing Spondylitis; Psoriatic Arthritis

Summary: the purpose of the study is to establish a danish cohort of spondylarthropathy (spa) patients who are being treated with tnfalfa blockers. by following the tnfalfa blocking treated patients the researchers want to identify better biomarkers for disease activity and disease progression. in addition, the researchers want to identify predictors for disease progression.


Eligibility criteria:
inclusion criteria: * age\>18 years old * spondylarthropathies according to the european spondylarthropathy study group (essg) criteria * sacroiliitis by x-ray or magnetic resonance imaging (mri) * bath ankylosing spondylitis disease activity index (basdai)\>3 * no signs of tuberculosis (tb) * sufficient contraception exclusion criteria: * wish of pregnancy or nursing * previous treatment with tnfalfa blocker * disease-modifying anti-rheumatic drugs (dmards) other than methotrexate (mtx) later than 4 weeks before inclusion * steroid treatment later than 4 weeks before inclusion * immunosuppressing agents later than 4 weeks before inclusion * severe infections within 3 months * hiv-infection * active hepatitis b and c * active or latent tb * severe chronic diseases * heart insufficiency (new york heart association \[nyha\] 3 and 4) * malignancy * systemic lupus erythematosus (sle) or sle-like disease * abuse of narcotics or alcohol * major psychiatric disorders
lenvatinib in second line endometrial carcinoma

Conditions: Endometrial Neoplasms

Summary: the primary objective of this multicenter, randomized phase ii trial is to assess the efficacy, as measured by progression-free survival (pfs), of lenvatinib compared to doxorubicin in advanced or recurrent endometrial cancer. the main secondary objective is to evaluate the predictive value of ang-2 on lenvatinib activity and establishing a cutoff value as potential selection criteria for phase iii. other secondary objectives are to assess the tolerability and safety of lenvatinib in this setting and overall survival, response and disease control.


Eligibility criteria:
inclusion criteria: * female subjects age ≥18 years at the time of informed consent * world health organization (who) performance status of 0 or 1 * patients with histologically confirmed endometrial cancer including serous-papillary and clear cell histologies. uterine carcinosarcomas are allowed. * radiographic evidence of disease progression according to recist 1.1 after 1 prior systemic, platinum-based chemotherapy regimen for metastatic or primary unresectable endometrial carcinoma for which no surgical or radiotherapy treatment options exist. * patients with disease progression following platinum-based chemotherapy administered as either adjuvant or neoadjuvant treatment are also eligible. * patients may have received prior radiotherapy and / or adjuvant chemotherapy for early high-risk disease * patients may not have received prior treatment with anthracyclines * blood samples available for retrospective central assessment of ang-2 level * patients may have had prior therapy providing the following conditions are met: * surgery and radiation therapy: wash-out period of 14 days and subjects must have recovered adequately from any toxicity and/or complications from radiotherapy and major surgery prior to starting therapy. * systemic anti-tumor therapy or any investigational agent: wash-out period of 21 days (or 5 x half-life) * recovery from any toxic effects of prior therapy to ≤ grade 1 per the national cancer institute common terminology criteria for adverse events (nci ctcae v4.) except alopecia * adequate contraceptive measures * signed written informed consent exclusion criteria: * inadequate hematologic, renal and hepatic functions * abnormal cardiac function
effects of the oral stimulation program in extreme preterm infants

Conditions: Infant, Premature; Feeding Behavior

Summary: the purpose of this study is to determine whether oral stimulation program are effective to improve oral feeding efficiency. the sample size estimated in 74 preterm, randomized classification of the subjects into to experimental and a control group.

recent studies have suggested that an oral stimulation program applied to preterm infants facilitates their oral feeding progress, improve breastfeeding rates in preterm infants and decreases the length of hospital stay. the objective of this study will evaluate the effect an oral stimulation program on the performance feeding, the length of the transition oral feeding, length of hospital stay and breastfeeding rates upon discharge. primarily, will be evaluated the effect an oral stimulation program on the performance feeding. all infants will be assessed by a speech pathologist blinded as to the group randomization. secondarily, will be observed the length of the transition oral feeding of the preterm infants, conducted by medical team and will be observed length of hospital stay. both groups will be monitored from when they were assigned to participate in the study until hospital discharge. all statistical will be conducted using statistical package for social sciences® version 18.0. the data will be analyzed for treatment group differences with chi-square or fisher's exact tests for the categorical variables and with non-parametric tests for the continuous variables.

Eligibility criteria:
inclusion criteria: * infants with between 26 and 32 weeks gestational age as determined by date of last menstruation and first trimester ultrasound or by clinical examination. exclusion criteria: * infants with medical complications, such as grades iii or iv intraventricular hemorrhage or periventricular leukomalacia * congenital diseases such as chromosomal or genetic abnormalities * bronchopulmonary dysplasia * necrotizing enterocolitis.

Keywords: infant, premature
a study of ro4607381 in stable coronary heart disease patients with recent acute coronary syndrome

Conditions: Coronary Heart Disease

Summary: this study will evaluate the potential of ro4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent acute coronary syndrome (acs) and evaluate the long term safety profile of the drug. eligible patients in stable condition will be randomized to receive either ro4607381 600mg po or placebo po, daily, together with a background of standard medication for acs (including aspirin, antihypertensives and statins). the anticipated time on study treatment is 2+ years, and the target sample size is 15,600 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=45 years of age; * recently hospitalized for acs; * clinically stable; * receiving evidence-based medical and dietary management of dyslipidemia. exclusion criteria: * uncontrolled diabetes; * clinically unstable; * severe anemia; * uncontrolled hypertension; * concomitant treatment with any other drug raising hdl-c (eg niacin, fibrates).
study to assess the safety, pharmacokinetics/dynamics of ds-1040b in subjects with acute submassive pulmonary embolism

Conditions: Pulmonary Embolism; Thrombotic Disease

Summary: this is a phase 1b, double-blind (participants and investigators), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, efficacy, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of ds-1040b in participants with acute submassive pulmonary embolism.


Eligibility criteria:
inclusion criteria: * male or female subjects, age 18 to 75 years admitted to hospital with a clinical diagnosis of acute pulmonary embolism (pe) categorized as low risk or intermediate-risk or submassive pe and for whom catheter-based therapy is not planned; * subjects must have a computed tomography angiography (cta) scan confirming the pe diagnosis and with at least one measurable index lesion in a segmental or larger pulmonary artery prior to randomization; * subjects should be in otherwise satisfactory health in the opinion of the investigator; * subjects must be able to provide written informed consent. exclusion criteria: * subjects with acute pe categorized as high-risk or massive, or who are hemodynamically unstable, evidenced by a heart rate \> 120 /min and a systolic blood pressure (sbp) of \ 40 mmhg since presentation; * subjects for whom use of a thrombolytic, either systemic or via catheter, is planned; * subjects with pe lesions only in the sub-segmental or smaller arteries; * subjects receiving any vitamin k antagonists (vkas) prior to randomization or receiving more than 36 hours treatment with low molecular weight (lmw) heparin in therapeutic doses prior to randomization; * subjects who had a prior intracranial hemorrhage, known arteriovenous malformation or aneurysm, head trauma, or evidence of active bleeding; * subjects who within 48 hours of randomization have used an anti-factor iia agent such as dabigatran or an anti-fxa agent such as rivaroxaban, apixaban, or edoxaban; * subjects who within 21 days prior to randomization have had gastrointestinal or genitourinary bleeding; * subjects who within 14 days prior to randomization have had major surgery or a lumbar puncture (or epidural steroid injection); * subjects with diagnosed active liver disease or with elevation of liver enzymes/bilirubin.

Keywords: venous thromboembolism (vte) pulmonary embolism (pe) acute submassive pulmonary embolism
effects of propofol on auditory event-related potentials and brain functional connectivity in patients with supratentorial glioma

Conditions: Propofol; Glioma; Auditory Event-related Potential (AERP); Electroencephalogram (EEG); Brain Network Connectivity

Summary: the growth of gliomas often infiltrates important brain tissues and impairs subcortical fiber transmission, resulting in changes in global brain network connectivity. most of the current anesthesia depth monitoring methods are based on healthy brain function population，which is difficult to reflect the sedation depth of glioma patients accurately. therefore, this study aims to explore the characteristics of brain network connectivity in glioma patients under different sedation depths by electroencephalogram (eeg) and auditory event-related potential (aerp) methods, which may provide a research basis for sedative titration and anesthesia depth identification in glioma patients.


Eligibility criteria:
inclusion criteria: 1. age 18 - 60 years old; 2. american society of anesthesiologists (asa) physical status rating i-ii; 3. supratentorial glioma (frontal, temporal, parietal, insular ；who grade i-iii); 4. native chinese speaker; 5. signed informed consent. exclusion criteria: 1. mallampati airway class≥iii; 2. bmi\>30kg/m2; 3. combined osas or stop-bang score≥3; 4. hearing impairment 5. combined epilepsy symptoms 6. recurrent or multiple intracranial tumors 7. concomitant other psychiatric or neurological disorders 8. pregnancy and lactation
thromboprophylaxis by low molecular heparin during the post-partum period

Conditions: Thromboembolic Disease

Summary: the purpose of this study is to determine the current level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol during the post-partum period. the institutional protocol is based on national and international guidelines.

venous thromboembolism (vte) became the 4th cause of maternal mortality and the 2nd direct cause of maternal mortality in france. the re are only few randomized studies on the thromboprophylaxis during the post-partum period. this expose some discrepancy between french guidelines, french society of anesthesia \& intensive care medecine (sfar) and national college of french gynecologists and obstetricians (cngof ). the duration and adequate dose of low molecular heparin prescriptions are unclear. the level of adequacy of thromboprophylaxis prescriptions at centre hospitalier sud francilien with the sfar recommendations appears to be less than 50 % in a preliminary unpublished study. since this assessment, institutional protocol synthesizing thromboprophylaxis guidelines during the post-partum was exposed and validated among medical staff (both anaesthesiologists ang obstetricians).

Eligibility criteria:
inclusion criteria: * \>18 ages * who had given birth at centre hospitalier sud francilien * hospitalized during the puerperium at centre hospitalier sud francilien * being informed of the clinical trial and had offered any opposition for data collection exclusion criteria: * curative treatment of thrombosis by low molecular-weight or unfractioned heparin during pregnancy or post-partum period * curative anticoagulant therapy for any cause

Keywords: thromboembolic disease thromboprophylaxis post-partum period pregnancy low molecular heparin
effect of nutritional management on riom in patients with advanced head and neck cancer

Conditions: Head and Neck Cancer; Nutrition Related Cancer; Radiation-Induced Mucositis

Summary: the goal of this clinical trial is to learn about the effect of nutritional management on radiation-induced oral mucositis in patients with advanced head and neck cancer during the peri-radiotherapy period . the main questions it aims to answer are: * \[question 1\]whether whole-course nutritional intervention can improve radiation-induced oral mucositis in patients with hnc. * \[question 2\]whether whole-course nutritional intervention can improve nutritional status and inflammation. participants will be treated according to the nccn guidelines. in addition, clinical pharmacists and registered dietitians provided nutritional intervention strategies based on clinical and nutritional assessments for the patients in the peri-radiotherapy nutrition group. researchers will compare clinical routine examination and nutritional indicators between the standard treatment group and the peri-radiotherapy nutrition management group to see if nutrition management effects.


Eligibility criteria:
inclusion criteria: * aged between 18 and 80 years old * advanced head and neck cancer (iii-iv inoperable) is clearly diagnosed * predicted survival time \> 3 months * radical radiotherapy combined with chemotherapy or immunotherapy was performed in our hospital * the patient has clear consciousness and no communication disorder * informed consent and voluntary participation in this study exclusion criteria: * patients with previous surgery or radiotherapy for head and neck cancer * patients with concurrent or previous history of other tumors * distant metastasis * patients with allergy, intolerance or contraindication to enteral nutrition or parenteral nutrition * severe renal insufficiency (egfr\<30ml/min/1.73m2) * combined with poorly controlled metabolic diseases such as diabetes * doctors or researchers deem that they are not suitable to participate in the study.

Keywords: head and neck cancer malnutrition radiation-induced oral mucositis nutrition management
extension trial of the long term safety of bibf 1120 in patients with idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the aim of this extension trial is to assess the long-term safety of bibf 1120 treatment in patients with idiopathic pulmonary fibrosis who have completed one year treatment and the follow up period in the double-blind phase iii placebo controlled parent trials (1199.32 and 1199.34), who wish to continue treatment with bibf 1120.


Eligibility criteria:
inclusion criteria: 1. signed informed consent consistent with international conference on harmonisation-good clinical practices (ich-gcp) and local laws prior to trial participation. 2. patients from trials 1199.32 or 1199.34 who completed the 52 weeks treatment period and performed the follow-up visit. exclusion criteria: 1. aspartate aminotransferase (ast), alanine aminotransferase (alt) \> 1.5 fold upper limit of normal (uln) (patients who completed the parent trial with transaminase values \> 1.5 fold uln but \< 3 fold uln are considered eligible) 2. bilirubin \> 1.5 fold uln 3. bleeding risk 4. planned major surgery within the next 3 months, including lung transplantation, major abdominal or major intestinal surgery. 5. new major thrombo-embolic events developed after completion of the parent trial. 6. time period \> 12 weeks between visit 9 of the parent trial and visit 2 of this study. 7. usage of any investigational drug after completion of the parent trial or planned usage of a specific investigational drug during the course of this trial. 8. a disease or condition which in the opinion of investigator may put the patient at risk because of participation in this trial or limit the patients' ability to participate in this trial. 9. alcohol or drug abuse which in the opinion of the investigator would interfere with trial participation. 10. pregnant women or women who are breast feeding or of child bearing potential not using two effective methods of birth control (one barrier and one highly effective non-barrier) for at least 1 month prior to visit 2 and/or not committing to using it until 3 months after end of treatment.
metabolic profile of users of hormonal and non-hormonal contraceptives

Conditions: Contraceptive Usage; Metabolic Syndrome; Body Weight Changes

Summary: evaluation of metabolic profile of users of hormonal and non-hormonal contraceptives during five years follow-up

were eligible for the study 489 women, followed in federal university of são paulo family planning service, who used the same contraceptive method during five year of follow-up, according to the service protocol, the patients, after had participated of a orientation group about contraceptives methods, elected one of them. after that, if the choice had been according to the eligibility criteria of world health organization, it was approved by a gynecologist. the contraceptive methods available were the intrauterine device (iud) oral contraceptives, including combined pills and progestin-only formulations, and depot medroxyprogestereone acetate. the study consisted in the evaluation of their medical records of weight, bmi, blood pressure, glycemia, seric levels of cholesterol and triglycerides, during the five years, and in the comparison of the differences of these data between the contraceptive methods.

Eligibility criteria:
inclusion criteria: * women in reproductive age followed in federal university of sao paulo family planning service * use of the same contraceptive method during five years exclusion criteria: * incomplete data

Keywords: contraception body mass index metabolic syndrome obesity
effects of montelukast in children with asthma

Conditions: Asthma

Summary: leukotriene receptor antagonists (ltras) reduce fractional exhaled nitric oxide (feno) concentrations in children with asthma, but the effect of ltra withdrawal on feno and lung function is unknown. we will aim to study the effect of treatment and withdrawal of montelukast, a ltra, on airway inflammation as reflected by feno and lung function in children with asthma. a double-blind, randomized, placebo controlled, parallel group study will be undertaken in 18 atopic children with mild persistent asthma who will be treated with oral montelukast (5 mg/day for 4 weeks) and 18 atopic children with mild persistent asthma who will receive matching placebo. a follow-up visit will be performed 2 weeks after montelukast or placebo withdrawal.


Eligibility criteria:
inclusion criteria: * children 6 to 14 yrs old, step 1 and step 2 gina (global initiative for asthma) guidelines * exhaled nitric oxide (no) \>20 ppb at visit 2 * symptoms more often than twice a day, fev1 equal or higher than 80% of predicted value and reversibility equal or higher than 12% to salbutamol, or a positive provocation test with methacholine, or exercise * no regular medication, inhaled short-acting beta-2 agonists for symptom relief exclusion criteria: * patient is hospitalized * patient has fev1 \< 80% predicted on visit 1 * patient has 2 or more nighttime awakenings for asthma per week or pef variability 30% or more * upper respiratory infection in the previous 3 weeks * treatment with glucocorticoids or ltras in the previous 4 weeks * treatment with inhaled glucocorticoids for more than 4 weeks in the previous year

Keywords: airway inflammation childhood asthma fractional exhaled nitric oxide leukotriene receptor antagonists lung function